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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Surgimesh Polymeric Surgical Mesh Recalled for Residual Adhesive Material

Agency Publication Date: June 17, 2025
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Summary

Chamberlain Technologies LLC is recalling 110 units of Surgimesh WN and Surgimesh XB polymeric surgical mesh products. This recall was initiated because residual adhesive material may still be present on the surface of the mesh sheets. While no incidents or injuries have been reported to date, the presence of foreign material on a surgical implant can lead to serious health complications for patients.

Risk

Residual adhesive material on a surgical implant can cause adverse tissue reactions, inflammation, or infection once the mesh is placed inside a patient's body. If you have had a procedure involving this mesh, you should consult with your healthcare provider to monitor for any unusual symptoms or complications.

What You Should Do

  1. The products affected by this recall are Surgimesh WN and Surgimesh XB Polymeric Surgical Mesh, specifically models T3030, Tintra R-1415, Tintra E-3030, and T1415.
  2. Check your surgical inventory for lot numbers Z2459757F, Z2459695M, Z2459757G, or Z2459757H, all of which have an expiration date of July 1, 2025.
  3. Stop using the recalled surgical mesh immediately and quarantine any remaining stock to prevent further use in clinical procedures.
  4. Contact Chamberlain Technologies LLC or your authorized distributor to arrange for the return, replacement, or correction of any affected units in your possession.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report any adverse events related to these devices.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet
Model / REF:
T3030
Lot Numbers:
Z2459757F (Exp 2025-07-01)
UDI:
(01)00850011929186(17)250701(10)Z2459757F

Reference Number: T3030

Product: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier
Model / REF:
Tintra R-1415
Lot Numbers:
Z2459695M (Exp 2025-07-01)
UDI:
(01)00850011929032(17)250701(10)Z2459695M

Reference Number: Tintra R-1415

Product: SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh
Model / REF:
Tintra E-3030
Lot Numbers:
Z2459757G (Exp 2025-07-01)
UDI:
(01)00850011929063(17)250701(10)Z2459757G

Reference Number: Tintra E-3030

Product: SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet
Model / REF:
T1415
Lot Numbers:
Z2459757H (Exp 2025-07-01)
UDI:
(01)00850011929155(17)250701(10)Z2459757H

Reference Number: T1415

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96930
Status: Active
Manufacturer: Chamberlain Technologies LLC
Sold By: Chamberlain Technologies LLC
Manufactured In: United States
Units Affected: 4 products (60 units; 20 units; 10 units; 20 units)
Distributed To: Illinois, Nebraska, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.